MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX GO; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, WGN TMX 30CT 24/CASE MG/DL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint for dead meter; customer initially also reported complaint for error messages (unknown).Coordinator had spoken with customer and transferred information to technician.When contacted by technician customer confirmed he did not receive error message.The battery in the meter had not been changed; per the customer he has only had the true metrix go meter for two days.The customer is using the correct battery in the correct orientation for the meter.During the call the meter did not power on using the power button or when a test strip was inserted.The customer reported feeling weak; medical attention was not needed at the time of the call.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to symptoms related to diabetes: weak.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-041: dead battery.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and the replacement products resolved the initial concern - unable to establish contact with customer at this time.

• Brand Name: TRUE METRIX GO
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 23921945
• Report Number: 1000113657-2025-00482
• Device Sequence Number: 21120241
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120(17)270331(10)ZD6220S
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STRIP, WGN TMX 30CT 24/CASE MG/DL
• Device Lot Number: ZD6220S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown